Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic

NCT02063321 | Unknown DMC

• 1 other identifier: LUB012013
• Study Type: observational
• Target: 762
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes, type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of prognostic factors leading to development of DME.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy

Keywords

DME, diabetic retinopathy, diabetes mellitus, epidemiology

Outcome Measures

Primary Outcomes (1)

• Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema

  Image of fundus taken in NIED securely sent via internet and electronic Clinical Report Form (eCRF) to ophthalmology reading center to assess stage and severity of potential retina damage, feedback to NIED within the stay of screened individual essential for further disease management

  Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days

Secondary Outcomes (5)

• Patient´s structure with DME and clinically significant DME in terms of demography and anamnesis of diabetes

  Patients screened during hospitalization in NIED, usually in 10 days

• Range of visual deterioration and occurence of blindness in relation to duration of diabetes

  Patients screened during hospitalization in NIED, usually in 10 days

• Prognostic factors, which determine the occurence of DME using explorative analysis

  Patients screened during hospitalization in NIED, usually in 10 days

• Range of visual deterioration and occurence of blindness in relation to type of diabetes

  Patients screened during hospitalization in NIED, usually in 10 days

• Range of visual deterioration and occurence of blindness in relation to general treatment (insulin vs. OAD or combination therapy)

  Patients screened during hospitalization in NIED, usually in 10 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults regularly examined in National Institute of Endocrinology and Diabetology (NIED) for their severity and complications of diabetes will undergo a screening procedure using fundus camera to assess the back of the eye (fundus examination).

You may qualify if:

• Adults ≥18 years treated in National Institute of Endocrinology and Diabetology
• Patients diagnosed with Diabetes mellitus type I and type 2 respectively
• Presence of Diabetes ≥10 years or patients with suspected visual impairment (duration of diabetes \<10 years)
• Signed patient´s information and informed content

You may not qualify if:

• Non-compliant patients

Sponsors & Collaborators

• Emil Martinka: lead
• Novartis Slovakia, s.r.o.: collaborator

Related Links

• Main Site of Principal Investigator

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marta Ondrejkova, MD

  II. Eye Clinic SZU of F.D.Roosevelt Hospital, Banska Bystrica

  STUDY CHAIR

• Monika Gajdosova, MD

  Oftal, s.r.o. Specialized Hospital for Ophthalmology, Zvolen

  STUDY CHAIR

• Emil Martinka, MD

  Department of Diabetology of National Institute for Endocrinology and Diabetology, Lubochna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Diabetology Department

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 14, 2014
• Study Start: December 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 14, 2014

Record last verified: 2014-02